Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers
|ClinicalTrials.gov Identifier: NCT01577732|
Recruitment Status : Completed
First Posted : April 16, 2012
Results First Posted : May 5, 2014
Last Update Posted : June 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acellular Pertussis Haemophilus Influenzae Type b Tetanus Poliomyelitis Diphtheria||Biological: Infanrix-IPV+Hib™||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||321 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+HibTM) in Healthy Vietnamese Toddlers|
|Study Start Date :||December 8, 2012|
|Actual Primary Completion Date :||April 9, 2013|
|Actual Study Completion Date :||April 9, 2013|
Experimental: Infanrix-IPV+Hib Group
Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
Single dose administered intramuscularly (IM) into the anterolateral side of the right thigh.
- Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: Within the 4-day (Days 0-3) follow up period after vaccination. ]Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
- Number of Subjects Reporting Solicited General Symptoms [ Time Frame: Within the 4-day (Days 0-3) follow up period after vaccination. ]Solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss of Appetite and Fever, defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C). Any = occurrence of a general symptom regardless of intensity grade or relationship to study vaccination.
- Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [ Time Frame: Within the 31-day (Days 0-30) follow up period after vaccination. ]An unsolicited AE was any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
- Number of Subjects Reporting Any Serious Adverse Events (SAEs). [ Time Frame: During the entire study period (Days 0-30). ]SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577732
|GSK Investigational Site|
|Hai Phong, Vietnam|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|